Site Contracts Lead

Overview

The organization is seeking a Site Contracts Lead to join the Regulatory Submissions and Contracts team.

This role supports biotech, medtech, and specialty pharma clients by ensuring study site contracting documents are implemented accurately, consistently, and in compliance with applicable legal requirements.

Responsibilities

• Manage all aspects of implementing Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), contract amendments, and other associated documents for assigned studies (site contracts).
• Ensure high-quality site contract documents and that they comply with consistent standards and local legal requirements for assigned studies.
• Manage end-to-end initiation and completion steps for site contracts in parallel with study start-up timelines and site initiation projections.
• Serve as the liaison with the client for status reporting and execution of all documents.
• Negotiate terms of site contract templates with each Sponsor at the beginning of each project.
• Serve as liaison between Sponsors and country experts during negotiations.
• Assist the Manager of Site Contracts with development and maintenance of templates for CTAs, NDAs, and other documents as needed; regularly review templates for compliance with local legal requirements and industry standards.
• Oversee site contracts with country experts during investigator site negotiation for assigned studies.
• Support quality by reviewing and advising on requested language and budget changes from investigator sites.
• Liaise with the Sponsor on management of sites’ requested changes; negotiate changes toward solutions with country experts.
• Establish and tailor templates for new studies by selecting appropriate templates and tailoring to study requirements; confirm suitability with the Sponsor and set negotiation parameters when possible.
• Confirm template suitability with local country experts when necessary.
• Work with Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions.
• Independently communicate with Regulatory Submission Managers on all contract-related items as needed per study.
• Escalate legal questions/issues appropriately to the Line Manager, Legal Counsel, or Sponsor.
• Proactively identify site contract and budget risks, potential controversies, and conflicts, and suggest solutions to resolve or mitigate them.
• Participate in internal and external project-related meetings as needed.
• Assist in development and implementation of new initiatives and processes in site contracts.
• Interact with clients and other functional areas as a secondary project contact for contracting issues and questions.
• Collaborate with internal study team members (including start-up team and Clinical Lead) to ensure client deliverables and expectations are met.
• Serve as the liaison for CTAs/NDAs between country-level experts and the client for assigned studies.
• Represent the Contracts Department during internal and Sponsor kick-off meetings.
• Help establish study contract negotiation timelines at the beginning of the Study and oversee site-contract-related milestones, deliverables, and deadlines throughout the Study.
• Liaise with internal stakeholders to review contract or budget areas that impact final execution of site contracts.
• Guide and support site contract negotiators to successful completion of study timelines and deadlines.
• Ensure contractual agreements are clear, fair, and legally binding for the organization, clinical investigators, institutions, and clients.
• Review and advise on Regulatory and Clinical Operations SOPs, WGs, and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney.
• Provide training on clinical site contractual requirements and negotiation.
• Mentor and train junior staff.
• Provide performance feedback on project team members for annual appraisals.
• Perform other activities as designated.

Requirements

• Experience managing site contracts and associated contracting processes for clinical studies, including NDAs, CTAs, contract amendments, and related documents.
• Ability to negotiate site contract template terms with Sponsors.
• Experience coordinating with country experts to ensure local legal compliance.
• Strong communication skills for client liaison and internal cross-functional coordination.
• Ability to manage timelines, milestones, deliverables, and deadlines in support of study start-up.

Preferred Qualifications

• Familiarity with Regulatory and Clinical Operations SOPs, WGs, and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney.
• Experience reviewing and advising on requested language and budget changes from investigator sites.
• Experience providing training and mentoring junior staff.

Compensation & Benefits

Not specified in the provided job description.

Location

Not specified in the provided job description.

Equal Opportunity

The organization is an equal opportunity employer and is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.